Bionet Co L T D

FDA Filings

This page includes the latest FDA filings for Bionet Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3003681187
FEI Number3003681187
NameHyun Y.Seo
Owner & OperatorBIONET COMPANY LTD
Contact Address5F, 61 Digital-ro 31 gil, Guro-gu
Seoul KR-11 Seoul Teugbyeolsi 08375 KR
Official Correspondent
  • DONG-JOO - KANG
  • 82-70-75856476-6476
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2691 DOW AVE, SUITE B
TUSTIN, CA 92780 US
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
Bionet Co., Ltd.
SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) And SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25)2022-10-11
Bionet CO,LTD
 Spiro Handle 2021-07-23
Bionet CO,LTD
 BM3/BM3 Plus 2021-07-23
Bionet CO,LTD
 FC1400 2021-07-23
Bionet CO,LTD
 FC700 2021-07-23
Bionet CO,LTD
 Cardio7 2021-07-23
Bionet CO,LTD
 CardioTouch3000 2021-07-23
Bionet CO,LTD
 CardioCare2000 2021-07-23
Bionet CO,LTD
 CardioXP 2021-07-23
Bionet CO,LTD
 SPM-300 2020-08-07
Bionet CO,LTD
 BIONET BM3PLUS PATIENT MONITOR 2020-05-06
Bionet CO,LTD
 BM3/BM3 PLUS 2020-05-06
Hyun Y.Seo [BIONET COMPANY LTD]
BM32013-12-10
Hyun Y.Seo [BIONET COMPANY LTD]
SpiroCare2013-12-03
Hyun Y.Seo [BIONET COMPANY LTD]
SPM-3002013-12-03
Hyun Y.Seo [BIONET COMPANY LTD]
CardioTouch3000-S2013-12-03
Hyun Y.Seo [BIONET COMPANY LTD]
Cardio7-S2013-12-03
BIONET CO., LTD.
SPM-3002013-11-15
Hyun Y.Seo [BIONET COMPANY LTD]
Cardio72012-07-24
BIONET CO., LTD.
CARDIO 72012-07-16
Hyun Y.Seo [BIONET COMPANY LTD]
CardioXP2011-07-22
BIONET CO., LTD.
CARDIO XP2011-06-03
Hyun Y.Seo [BIONET COMPANY LTD]
EKG-PLUS ll2009-09-09
BIONET CO., LTD.
EKG-PLUS II SOFTWARE2009-08-26
Hyun Y.Seo [BIONET COMPANY LTD]
BM3 Plus2009-02-02
BIONET CO., LTD.
BIONET BM3PLUS PATIENT MONITOR2008-12-11
Hyun Y.Seo [BIONET COMPANY LTD]
SX30002007-12-07
Hyun Y.Seo [BIONET COMPANY LTD]
CARDIOTOUCH-30002007-12-07
Hyun Y.Seo [BIONET COMPANY LTD]
SX20002007-12-07
Hyun Y.Seo [BIONET COMPANY LTD]
CARDIOCARE-20002007-12-07
Hyun Y.Seo [BIONET COMPANY LTD]
FC 14002006-06-30
Hyun Y.Seo [BIONET COMPANY LTD]
FC 7002006-06-30
BIONET CO., LTD.
FC 1400 FETAL MONITOR2005-12-16
BIONET CO., LTD.
FC 700 FETAL MONITOR2005-12-16
BIONET COMPANY LTD
CARDIOTOUCH-30002002-11-14
BIONET COMPANY LTD
CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH2001-11-21

Related Finance Registrations
NCAGE Code9187FBIONET CO.,LTD
CAGE Code9187FBIONET CO.,LTD BIONET
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020091189644Pusan,South Korea -> Los Angeles, CaliforniaPATIENT MONITOR 9018.1920 PKG
2020091189642Pusan,South Korea -> Los Angeles, CaliforniaPATIENT MONITOR 9018.1931 PKG
2020081759355Pusan,South Korea -> Long Beach, CaliforniaPATIENT MONITOR12 PKG
2020071350277Pusan,South Korea -> Long Beach, CaliforniaPATIENT MONITOR 9018.1916 PKG
2020050143424Pusan,South Korea -> Long Beach, CaliforniaHAND SANITIZERDG CLASS 3 UN 117020 PKG
2020041045517Pusan,South Korea -> Long Beach, CaliforniaPATIENT MONITOR 9018.1926 PKG
2020031339700Pusan,South Korea -> Long Beach, CaliforniaPATIENT MONITOR 9018.1941 PKG
2020020854255Pusan,South Korea -> Los Angeles, CaliforniaACCESSORY 9018.1960 CTN
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.